Regulatory Life Cycle Management Scientist

CK Group are recruiting for a Regulatory Life Cycle Management Scientist to join a biopharmaceutical company who are based in Reading on a contract basis for 12 months.

Company:

Out client is a global consumer healthcare business with well known household brands.

Location:

The role is based in Reading.

Role:

• Coordinate Regulatory Life Cycle Management activities across multiple countries within and outside Europe.
• Coordinate with Local Regulatory Affairs for variations, renewals and answering health authority requests.
• Maintain Global Master Dossiers and compile, review, and provide dossiers for local registration and compliance to achieve variations for the specific product portfolio.
• Ensure regulatory assessments are conducted for change controls in the respective Veeva Quality Tracking system.
• Ensure that the Veeva Regulatory Information Management system is maintained and updated for all activities under role responsibility, including review of documents.
• Provide strategic input into Regional Product labelling and approval to enable commercial activation of product launches.

Your Background:

• Educated to ideally Masters’ degree level in pharmacy, engineering, chemistry or a similar field.
• Regulatory affairs experience, preferably in consumer health and preferably across multiple regulatory classification areas.
• Experience of dossier maintenance and product change management as well as working with complex Regulatory databases.
• Excellent attention to detail, good communication and presentation skills.

Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 103371 in all correspondence.